2754e9bf-8c81-45b6-b243-993b9c4f9956

SPL v6
SPL
SPL Set ID 2754e9bf-8c81-45b6-b243-993b9c4f9956
Route
topical
Published
Effective Date 2021-01-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (1 g)
Inactive Ingredients
water cetrimonium chloride laurtrimonium chloride cocamidopropyl propylene glycol-dimonium chloride phosphate dihydroxyethyl cocamine oxide citric acid monohydrate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2014-04-01

Purpose

Antimicrobial

Description

Drug Facts


Medication Information

Warnings
  • For external use only
Uses
  • For hand sanitizing to decrease bacteria on the skin.
  • Recommended for repeated use.
Purpose

Antimicrobial

Directions
  • Hands must be washed and rinsed with potable water before use.
  • Pump a small amount of foam into palm of hand.
  • Rub thoroughly over all surfaces of both hands.
  • Rub hands together briskly until dry.
Other Information
  • This product must be dispensed from an adequate dispenser located a sufficient distance from processing line to prevent accidental product contamination.
  • Do not contaminate water, food or feed by storage and disposal.
Inactive Ingredients

Water, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxethyl Cocamine Oxide, Glycereth-17-Cocoate, Citric Acid

Description

Drug Facts

Questions?

1 -800-537-8990

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if irritation and redness develops, or if condition persists for more than 72 hours.

Section 50567-7

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Active Ingredients

Benzalkonium Chloride 0.1%

Principal Display Panel Container Label


Structured Label Content

Warnings
  • For external use only
Uses
  • For hand sanitizing to decrease bacteria on the skin.
  • Recommended for repeated use.
Purpose

Antimicrobial

Directions
  • Hands must be washed and rinsed with potable water before use.
  • Pump a small amount of foam into palm of hand.
  • Rub thoroughly over all surfaces of both hands.
  • Rub hands together briskly until dry.
Other Information
  • This product must be dispensed from an adequate dispenser located a sufficient distance from processing line to prevent accidental product contamination.
  • Do not contaminate water, food or feed by storage and disposal.
Inactive Ingredients

Water, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxethyl Cocamine Oxide, Glycereth-17-Cocoate, Citric Acid

Questions?

1 -800-537-8990

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation and redness develops, or if condition persists for more than 72 hours.

Section 50567-7 (50567-7)

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Active Ingredients

Benzalkonium Chloride 0.1%

Principal Display Panel Container Label (Principal Display Panel - Container Label)


Advanced Ingredient Data


Raw Label Data

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